MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-01-14 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare, Inc..
[19256942]
Pt admitted to icu in the evening after their 1st prosorba treatment "ventilated and posturing". They were diagnosed with basal ganglia stroke possibly due to hypertensive crisis. Results of ct were negative however info is pending on a 2nd ct. According to the apheresis provider, the pt's bp was very high on admission. This pt had not taken their antihypertensive medications prior to their treatment and a family member revealed that they did not take them after they returned home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032792-2005-00001 |
| MDR Report Key | 566284 |
| Report Source | 05 |
| Date Received | 2005-01-14 |
| Date of Report | 2005-01-13 |
| Date of Event | 2004-12-13 |
| Date Facility Aware | 2004-12-16 |
| Date Mfgr Received | 2004-12-16 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2005-01-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAREN QUARFORD |
| Manufacturer Street | 14715 NE 95TH ST SUITE 100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4252422154 |
| Manufacturer G1 | FRESENIUM HEMOCARE |
| Manufacturer Street | 14787 NE 95TH STREET |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98052 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSORBA COLUMN |
| Generic Name | PROSORBA COLUMN |
| Product Code | LQQ |
| Date Received | 2005-01-14 |
| Model Number | 9798701 |
| Catalog Number | 9798701 |
| Lot Number | QHN001A |
| ID Number | * |
| Device Expiration Date | 2006-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 556070 |
| Manufacturer | FRESENIUS HEMOCARE, INC. |
| Manufacturer Address | 14787 NE 95TH ST. REDMOND WA 98052 US |
| Baseline Brand Name | PROSORBA COLUMN |
| Baseline Generic Name | THERAPEUTIC PLASMA EXCHA |
| Baseline Catalog No | 9798701 |
| Baseline Device Family | PROTEIN A IMMUNOADSORPTION COL |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | Y |
| Premarket Approval | P8500 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-01-14 |